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Diss Factsheets
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EC number: 211-892-8 | CAS number: 706-14-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
- Acute toxicity: oral: LD50 > 2000 mg/kg bw (WoE)
- Acute toxicity: dermal: LD50 > 2000 mg/kg bw/f (WoE)
- Acute toxicity: inhalation: waiving
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1975
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only short abstract available. No certificate of analysis of the test item.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no details on test animals and environmental conditions; no details on results
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- None
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- None
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- Total animals: 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- None
- Preliminary study:
- Not applicable
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One animal died on Day 1
- Clinical signs:
- other: Slight letargy was noticed
- Gross pathology:
- No data
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 of γ-Decalactone is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Annex VI of the Directive 67/548/EEC and of the Regulation (EC) N° 1272-2008 (CLP).
- Executive summary:
In an acute oral toxicity (limit test) study, a group of 10 rats were given a single oral dose of γ-Decalactone at 5000 mg/kg bw. Animals were then observed for 14 days.
During the observation period, slight lethargy was noticed and one animal died on Day 1.
Oral LD50 > 5000 mg/kg bw in rats.
The oral LD50 of γ-Decalactone is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008 (CLP).
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available information as a whole meets the tonnage driven data requirement of REACH. Moreover, reliability and consistency are observed across the different studies.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available information as a whole meets the tonnage driven data requirement of REACH. Moreover, reliability and consistency are observed across the different studies.
Additional information
Acute toxicity: oral
Due to the poor description of the only study conducted on γ-Decalactone, a weight of evidence approach was used to evaluate its acute oral toxicity. This approach is based on the similarity between aliphatic γ-lactones (see §"Toxicokinetics" for read-across justification).
In the γ-Decalactone study (Moreno, 1975, rel.4), rats were given a single dose of test material and observed for 14 days. The oral LD50 was higher than 5000 mg/kg bw/d. However, the protocol and results were poorly reported and the substance purity was not mentioned. Therefore, the result was not considered sufficiently robust and read-across data were required to conclude on acute oral toxicity.
The combined LD50 of γ-Caprolactone was higher than 2000 mg/kg bw in a limit test performed similarly to the OECD test guideline No. 420 (Sunaga, 2002, rel. 2). In the same way, the male LD50 of γ-Nonalactone was calculated to be 6600 mg/kg bw in an OECD 401 study (Moreno, 1972, rel.2).
Based on all available data, the acute oral LD50 value was considered to be higher than 2000 mg/kg bw and to be a worst-case for the hazard assessment purpose.
Acute toxicity: dermal
Due to the poor description of the only study conducted on γ-Decalactone, a weight of evidence approach was used to evaluate its acute dermal toxicity profile. This approach is based on the similarity between aliphatic γ-lactones (see §"Toxicokinetics" for read-across justification).
In the the γ-Decalactone study (Moreno, 1975, rel.4), rabbits were administered a single dermal dose of the test material and were observed for 14 days. The dermal LD50 was higher than 5000 mg/kg bw. No mortality was observed during the observation period. Slight redness (2/10), moderate redness (8/10), slight edema (1/10) and moderate edema (9/10) were noticed. However, the protocol and results were poorly reported and the substance purity was not mentioned. Therefore, the result was not considered sufficiently robust and read-across data were required to conclude on acute dermal toxicity.
The dermal LD50 of γ-Nonalactone was higher than 5000 mg/kg bw based on two limit acute dermal studies (Moreno, 1973, rel.3 & Levenstein, 1976, rel.4) and the dermal LD50 of γ-Undecalactone was higher than 2000 in an OECD 402 & GLP study (Sanders, 1999, rel.2).
Based on all available data, the acute dermal LD50 value was considered to be higher than 2000 mg/kg bw and to be a worst-case for the hazard assessment purpose.
Acute toxicity: inhalation
No data was available. However, in accordance with column 2 of REACH Annex VIII (§8.5), the acute toxicity by inhalation does not need to be conducted since the acute toxicity study is already provided for both the oral and the dermal routes. Moreover, γ-Decalactone has a low vapor pressure (0.72 Pa at 25 °C) and therefore the potential for the generation of an inhalable form is low.
Justification for selection of acute toxicity – oral endpoint
Due to the poor description of the only study conducted on γ-Decalactone, a weight of evidence approach was used to evaluate its acute oral toxicity based on the similarity between aliphatic γ-lactones (see §"Toxicokinetics" for read-across justification).
Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH Annex VIII (§8.5), the acute toxicity by inhalation does not need to be conducted since the acute toxicity study is already provided for both the oral and the dermal route.
Justification for selection of acute toxicity – dermal endpoint
Due to the poor description of the only study conducted on γ-Decalactone, a weight of evidence approach was used to evaluate its acute dermal toxicity profile based on the similarity between aliphatic γ-lactones (see §"Toxicokinetics" for read-across justification).
Justification for classification or non-classification
Harmonized classification:
γ-Decalactone has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP2.
Self classification:
Based on the available data no additional self-classification is proposed regarding:
- both acute oral and dermal toxicity and,
-specific target organ toxicity -single exposure
according to the Regulation (EC) No. 1272/2008 (CLP) and of the Directive 67/548/EEC. No data were available by inhalation.
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